Sangamo Therapeutics, Inc.
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Latest From Sangamo Therapeutics, Inc.
While not an outright rejection, the Deficiencies Preclude Discussion letter came as a surprise given the expectation of the drug’s approval for hyperphosphatemia in adults with chronic kidney disease on dialysis.
Revenues are still elusive for a surprising number of the novel drugs approved by the FDA five years ago. Emergent safety issues and confirmatory clinical trial failures were less common than lack of competitiveness as the main reason for revenue weakness.
April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use
While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.
Building on Oxbryta, which is already approved in the US for the rare blood disorder, Global Blood Therapeutics has licensed two sickle cell disease programs from Sanofi.
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